Good afternoon. My name is Diego and I will be your conference call operator today. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin your conference.

Thank you, Diego. Good afternoon and welcome to Puma’s conference call to discuss our financial results for the second quarter of 2024. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; and Jeff Ludwig, Chief Commercial Officer. After market closed today, Puma issued a news release detailing second quarter 2024 financial results. That news release, the slides that Jeff will refer to, and a webcast of this call are accessible via the homepage and Investors sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days. Today’s conference call will include statements about Puma’s future expectations, plans and prospects that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time-to-time, including our Annual Report on Form 10-K for the year ended December 31, 2023. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, August 1, 2024. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law. During today’s call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics maybe useful to investors as a supplement to, but not a substitute for our GAAP financial measures. Please refer to our second quarter 2024 news release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Thank you, Mariann and thank you all for joining our call today. Today, Puma reported total revenue for the second quarter of 2024 of $47.1 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales as well as royalties from our sub-licensees. Product revenue net was $44.4 million in the second quarter of 2024 which was an increase from the $40.3 million reported in Q1 of 2024 and below the $51.6 million reported in Q2 of 2023. Product revenue for the second quarter of 2024 was impacted by approximately $2.3 million of inventory drawdown in our specialty pharmacies and specialty distributors. Royalty revenue was $2.7 million in the second quarter of 2024 compared to $3.5 million in Q1 of 2024 and $3.0 million in Q2 of 2023. We reported 2,515 bottles of NERLYNX sold in the second quarter of 2024, an increase of 105 bottles from the 2,410 bottles sold in Q1 2024. In Q2 2024, we estimate that inventory decreased by about 132 bottles. In Q2 2024, new prescriptions were down approximately 9% compared to Q1 2024 and total prescriptions were up approximately 3% compared to Q1 of 2024. Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter and then Jeff Ludwig will add additional color on NERLYNX commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the first quarter of 2024. As we have previously discussed, Puma has initiated a Phase 2 study of our investigational drug, alisertib to confirm the efficacy of alisertib monotherapy in patients with small cell lung cancer with biomarkers where aurora kinase pathway plays a role. The goal is to correlate the efficacy in these biomarker subgroups in the ALISCA-Lung1 study…

Thanks, Alan. Appreciate it. And thanks to everyone for joining our second quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward-looking statements, let me start out by reiterating our strategy. The commercial team remains largely focused on the extended adjuvant indication where the majority of NERLYNX sales and opportunity exists. Our commercial messaging is focused on HER2-positive patients that are deemed to be at higher risk of reoccurrence. A significant portion of these early-stage breast cancer patients are treated in the community oncology setting, and are being seen across a large number of community oncologists. Given this distribution of patients, our sales and marketing teams are focused on efficiently increasing reach and frequency for both personal and non-personal promotion with an emphasis on trying to reach customers when decisions are being made for the extended adjuvant setting. HCP calls in the second quarter increased about 6% quarter-over-quarter, but declined about 8% year-over-year. The year-over-year decline was driven by the timing of vacancies. In the second quarter, greater than 80% of calls were live interactions. We are continuing to evaluate new data and vendor partners that would allow us to operate more efficiently and effectively with the goal of balancing the needs of NERLYNX with the goals of the broader organization. Let me transition now into some of the commercial slides where I will provide some additional specifics around performance. Once I am finished, I will turn the call over to Maximo for a more detailed review of our financial results. Slide 3 provides an overview of our distribution model. This model has not changed and remains separated into two distinct channels, the specialty pharmacy channel and the specialty distributor channel or in-office dispensing channel. We do typically see quarterly fluctuations,…

Thanks, Jeff. I will begin with a brief summary of our financial results for the second quarter of 2024. Please note that I will make comparisons to Q1 2024, which we believe is a better indication of our progress as a commercial company and year-over-year comparisons. For more information, I recommend that you refer to our Q2 10-Q, which will be filed today and includes our consolidated financial statements. For the second quarter of 2024, we reported a net loss based on GAAP of $4.5 million or $0.09 per share. This compares to a net loss in Q1 2024 of $4.8 million or $0.10 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported a net loss of $2.5 million or $0.05 per share for the second quarter of 2024. Gross revenue from NERLYNX sales was $55.8 million in Q2 2024 and $52.6 million in Q1 2024. As Alan mentioned, net product revenue from NERLYNX sales was $44.4 million, an improvement from the $40.3 million reported in Q1 2024. Higher demand and lower gross net adjustments drove the higher sales versus Q1 2024. Inventory drawdown by our distributors was approximately $2.3 million in Q2 versus approximately $2 million of drawdown in Q1 2024. Royalty revenue totaled at $2.7 million in the second quarter of 2024 compared to $3.5 million in Q1 2024. Our gross net adjustment in Q2 2024 was about 20.4% compared to the 23.4% gross net adjustment reported in Q1 2024. Lower Medicaid share, coverage gap and lower co-pay were the main drivers of the decline versus Q1 2024. Cost of sales for Q2 2024 was $10.7 million, including $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q1 2024 was…

Thanks, Maximo. Puma’s senior management, in cooperation with Board of Directors, continues to remain focused on NERLYNX sales trends in 2024 and beyond, and recognizes its fiscal responsibility to shareholders to continue to maintain positive net income. In the fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operating cash flows. We believe the positive net income that was seen in 2023 resulted from these expense reductions. The expense reductions that we have previously performed and continue to perform are also a major contributor to the positive net income that the company is guiding forward for full year 2024. The company remains committed to continuing to achieve this positive net income, and will continue to reduce expenses if needed to achieve this in the future. We look forward to updating investors on this in the future. There continues to remain a significant unmet need for patients battling breast cancer, lung cancer and other solid tumors. We at Puma are committed and passionate about finding more effective ways at helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today’s presentation. We will now turn the floor back to the operator for Q&A. Operator?

[Operator Instructions] Your first question comes from Marc Frahm with TD Cowen. Please proceed with your question.

Thanks for taking my questions. Maybe just on the planned disclosure around ALISCA1 in Q4 or late in the year. I mean, can you just walk through – and thanks for the granularity that we don’t often see on patient enrollment heading into it. But 9 is not a ton of patients, and maybe response data on just 9 patients wouldn’t be the most meaningful. I know you intend to have a few more. How kind of rigid is that timeline to presenting data no matter what in Q4 versus is it really in your head a number of patients that you want to get to, and if – and you’re hoping that’s Q4, but if it happens to be Q1, you’d get – you’d push it out? That’s one question. And then the other is just, can you just run through the latest on some of these subsets based on the genetic background, just so what do we know about the outcomes for those patients on kind standard of care, and therefore how to comp your data when you do show it for those subsets?

Yes, Mark, thanks for the question. So first of all, Mark, there’s 12 patients currently enrolled, not 9.

Sorry, 12.

12, yes. And then several are in screening. So look, it’s August. So if we present the data, let’s say, in December, obviously, more time to get more patients too, right? So, will it be 12, will be 15, don’t know. I would rather be a good steward of shareholder capital and present data even if early just so that people know what’s happening rather than kind of just delay it till we get to some magic number or something. We obviously have the two things we’re looking at. We have the safety aspect of it and the efficacy aspect of it. As you’ll remember, in the trial that was done and published in the Journal of Thoracic Oncology, which was the paclitaxel plus alisertib against paclitaxel-placebo, we would anticipate that would be our future randomized trial for full approval. In that study, from the safety perspective, I don’t have the numbers in front of me, but it’s like – early in the study, it was like 30% of the patients couldn’t tolerate the paclitaxel plus alisertib combination due to neutropenia. So that obviously compromised that arm. So clearly, using the prophylactic G-CSF, if we can reduce the neutropenia and improve the tolerability, I would obviously think that would portend for a more favorable future randomized trial there as well. In terms of the efficacy side of it, so we mentioned the previous data in Lancet Oncology. The main difference between those patients and the ones we’re testing now is, at the time the Lancet Oncology study was going on, I/O had not really been incorporated in the standard of care. So I don’t think any of those patients have seen prior I/O. All of our patients will have seen that because now that’s standard of care. Does that change anything? I don’t know why it would, but that’s why you do these studies, obviously. Now in terms of the various biomarkers and subgroups, et cetera, I mentioned a lot of the genetic subgroups. I don’t know from a regulatory perspective how much those will play a role. So that would be a future discussion with FDA. In terms of the biomarkers that we are involved in the aurora kinase pathway such as c-Myc, such as RB1 loss and things like that, if you go and look at the randomized study, which was the study of the Journal of Thoracic Oncology paclitaxel-alisertib against paclitaxel alone, the patients who had those biomarkers, whether it was a c-Myc amplification or a RB1 loss of function mutation, my recollection is those tended to do worse than the ITT group. So that should – I would perceive select for a higher risk group patients.

Okay. Thank you.

Sure.

Thank you. And this concludes our question-and-answer session. I would like to turn the conference back to Mariann for closing remarks. Actually, one moment, one question just came up. My apologies. We do have one that just came up. And that question comes from Ed White with H.C. Wainwright. Please proceed with your question.

Hi, thanks for taking my questions. Just a question on sales in the U.S. Guidance was given for NERLYNX sales on the first quarter results conference call. It was changed during the year – during the quarter. And then you just reported numbers to actually hit the original numbers. So I’m just wondering what was changing within the quarter that had to change your guidance? And then the second question is just on the royalty number. You’re having a huge bolus of revenues expected for royalties in the third quarter. I’m just wondering what’s the reasons behind that? Thank you.

Hi, Ed, it’s Alan. On your first comment, we didn’t change our Q1 revenue guidance for NERLYNX. Can you clarify that? We have no – we’re all looking at each other very puzzled here around the table. We never changed our guidance. So can you clarify that?

I’m sorry. I had that you had original guidance that you gave in the first quarter for the second quarter of $43 million to $45 million for the second quarter. And then during the quarter in a PowerPoint presentation that you had on your website, the guidance was changed to $38 million to $40 million, unless I’m mistaken and maybe I was looking at an older presentation.

Yes. We never changed this.

Okay. Thanks, Alan. That’s my mistake, and I apologize.

We checked the website. I don’t have any – I apologize, Ed. I’m not – I was not aware there was a presentation put at the website doing that. If it was, it was an error. We never changed the Q2 revenue number. There was no revenue guidance change. So I apologize if, for some reason, that happened. We will check on that error. It was never – it may have been some older presentation or something that somehow got linked somewhere or something, but we never changed our Q2 revenue, U.S. NERLYNX revenue guidance. Any Q2 guidance was never changed from what we put out on our Q1 earnings call.

Okay. Thanks, Alan, for the clarification…

No, it’s my apologies for the confusion. I wish I was aware of that earlier. I didn’t know that. So again, we’ll check on that. We’ll get back to you. Thank you for bringing it to our attention. On the second one, which is the bolus in the royalties, for all of our – the various regions, we get our royalties at – basically as they’re sold, if you will. So it’s kind of direct. The one outlier is in China, which is that we get our sales kind of when they’re sold into the channel. And so that’s what gets this lumpiness. So kind of if you look at our historical royalties, you’ll always see like once a year or so, this big bolus and that’s usually just one big shipment into China. So it’s not based on end-user demand, it’s more based on sales into the channel. So, we get this lumpiness. It happens once a year. I realize it creates some confusion, but that’s the nature of the way the agreement is set up.

Okay, Alan.

Thank you.

Thank you. And that concludes our question-and-answer session. I would like to turn the conference back to Mariann for closing remarks.

Thank you for joining us today. As a reminder, this call may be accessed via replay of the webcast at pumabiotechnology.com beginning later today. Have a good evening.

Ladies and gentlemen, thank you for participating in today’s conference call. This concludes our program. Everyone, have a great day. You may now disconnect.